Is Botulinum toxin type a authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Botulinum toxin type a: Nuceiva.

Is Botulinum toxin type a authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Botulinum toxin type a, including NUCEIVA 50 U POWDER FOR SOLUTION FOR INJECTION; RELFYDESS 100 UNITS/ML SOLUTION FOR INJECTION.

Active substance

Botulinum toxin type a

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Nuceiva Evolus Pharma B.V. · Authorised · authorised 27 Sep 2019 · ATC M03AX01

Therapeutic indication (EMA)

Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
NUCEIVA 50 U POWDER FOR SOLUTION FOR INJECTION	PLGB 55681/0002	EVOLUS PHARMA B.V.	POM
RELFYDESS 100 UNITS/ML SOLUTION FOR INJECTION	PL 03070/0010	IPSEN BIOPHARM LIMITED	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.